ANATOMY INDEPENDENT DEFLECTOR
In general, the invention features an intra-vascular device ( 100 ) for filtering or deflecting emboli other large objects from entering a protected secondary vessel or vessels. The device of the invention may include a filter ( 201 ) to prevent a particle in a blood vessel from passing through the filter, a lateral structure ( 200 ) to hold the filter, and two wires ( 202, 203 ) attached the lateral structure, one each at its distal and proximal ends ( 206 a, 206 b ). These wires may be used to control the deflection or orientation of the filter upon its installation within a blood vessel. Further, in some embodiments, these wires may be capable of readily detaching from the device, thus making it possible to install a filter without any significant appendages in a blood vessel.
1 . A device for deflecting emboli, the device comprising:
a lateral structure circumscribing an elongate shape, a length of said lateral structure being between 80 mm and 120 mm and a width of said lateral structure being from 30 mm to 45 mm;
a substantially planar, elongate filter attached to the length and width of said lateral structure;
a first wire attached to the distal end of said lateral structure; and
a second wire attached to the proximal end of said lateral structure;
wherein said lateral support structure is sized such that upon installation of said device in the aortic arch of a human subject, it contacts the upper walls of said aortic arch.
2 . The device as in claim 1 , wherein said first wire further comprises a screw-like mechanism positioned at its distal end and said filter or said lateral structure comprises a mating component at its distal end suitable to receive said screw-like mechanism.
3 . The device as in claim 2 , wherein said mating component comprises a bead attached at the distal end of said filter or said lateral structure.
4 . The device as in any one of claims 1 - 3 , wherein said filter extends beyond the perimeter circumscribed by said lateral structure.
5 . The device as in any one of claims 1 - 3 , wherein said first wire is stiffer than said second wire, or said second wire is stiffer than said first wire.
6 . The device as in any one of claims 1 - 3 , wherein said first wire and said second wire are of equal stiffness.
7 . The device as in any one of claims 1 - 6 , wherein said device is made from metal wire.
8 . The device as in any one of claims 1 - 6 , wherein said device is made from Nitinol wire.
9 . The device as in any one of claims 1 - 8 , wherein the diameter of said wire is about 0.5 mm or less.
10 . The device as in claim 9 , wherein said lateral structure comprises two or more twists of said wire having a diameter less than about 0.5 mm
11 . The device as in any one of claims 1 - 10 , wherein said device further comprises radiopaque markers.
12 . The device as in any one of claims 1 - 11 , wherein, upon installation in an aortic arch, said lateral structure forms a seal with the walls of the aortic arch.
13 . The device as in any one of claims 1 - 12 , wherein said filter is not significantly permeable to emboli having a dimension of greater than 50, 100, or 200 μm.
14 . The device as in any one of claims 1 - 13 , wherein said first or second wire comprises readily malleable wire.
15 . The device as in any one of claims 1 - 14 , wherein said first or second wire is attached to said filter.
16 . The device as in any one of claims 1 - 15 , wherein said second wire is a hollow tube.
17 . The device as in any one of claims 1 - 16 , wherein said lateral structure further comprises two balls or tips at said distal and proximal ends.
18 . The device as in any one of claims 1 - 17 , wherein said first wire and/or said second wire includes a snare, and said proximal and/or distal end of said filter includes a bead, or other receiving element, that joins with said snare.
19 . The device as in any one of claims 1 - 18 , wherein said filter further comprises a hollow tube positioned along the length of said filter.
20 . A system comprising the device as in any one of claims 1 - 19 , wherein said device is loaded into a catheter.
21 . The system of claim 20 , wherein said catheter further comprises a guide wire.
22 . The system as in claim 20 or claim 21 , wherein said distal end of said system comprises a protected lip.
23 . The system as in any one of claims 20 - 22 , wherein said protected lip further comprises a dilator.
24 . The system as in any one of claims 20 - 23 , wherein said dilator is positioned distal to said catheter and has a smaller diameter than said catheter.
25 . The system as in any one of claims 20 - 24 , wherein said lateral structure and filter of said device is compressed within said catheter and positioned behind said dilator.
26 . The system as in any one of claims 20 - 25 , wherein said lateral structure and filter of said device expands upon the retraction of said catheter relative to said lateral structure and filter of said device.
27 . The system as in any one of claims 20 - 26 further comprising a pigtail catheter.
28 . The system as in any one of claims 20 - 27 , wherein the opening of said catheter is not perpendicular to the longitudinal axis of said catheter.
29 . A method of introducing the system of any one of claims 20 - 28 into a subject, said method comprising:
(i) inserting into a blood vessel of said subject said device contained within a catheter,
(ii) and retracting said catheter at a desired location in said blood vessel, thereby deploying said device.
30 . The method of claim 29 , wherein said device is deployed from said catheter into the aortic arch.
31 . The method of claim 29 or 30 , further comprising introducing a pigtail catheter through said catheter.
32 . The method of any one of claims 29 - 31 , wherein said device is advanced through said catheter by said first wire.
33 . The method of any one of claims 29 - 32 , wherein said device is positioned within said aortic arch by antagonistically pushing and pulling on said first and said second wires.
34 . The method of any one of claims 29 - 33 , wherein said pigtail catheter is inserted over a guide wire, and said guidewire is retracted through said catheter prior to deployment of said device.